FDA approval

Finceramica has obtained the US product marketing authorization issued by the Food and Drug Administration (FDA).

CustomizedBone Service, which is how the well-known CustomBone Service is trademarked in the US, obtained this approval following the submission of a "510k" file, aimed at proving substantial equivalence of the Italian device to at least another (predicate) device already legally marketed in the US, hence, already FDA approved. The dossier must be complete with, among other things, product details, comparative tests, and clinical data. The time required for approval generally depends on the complexity of the case and on how equivalent the compared devices actually are. CustomizedBone was a particular case, as this is the only FDA approved porous hydroxyapatite device for this type of therapeutic indication.